SolAeroMed PP March 25 2015.pptx

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BIOPHYSICAL RESPIRATORY DRUGS
AND DELIVERY DEVICES
Dr. John Dennis, CEO co-founder
Prof Francis Green, CSO & co-founder
Gareth Lewis, CFO
March 25, 2015
Forward Looking Statements Advisory
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Certain of the information provided in this presentation of SolAeroMed Inc. (the "Company") may constitute forward-looking statements and
forward-looking information (collectively, "forward-looking statements") within the meaning of applicable securities legislation and is based on
the expectations, estimates and projections of management of the Company as of September 2013 unless otherwise stated. The use of any
of the words "expect", "anticipate", "continue", "estimate", "objective", "ongoing", "may", "will", "project", "potential", "should", "believe",
"plans", "intends" and similar expressions are intended to identify forward-looking information. More particularly and without limitation, this
presentation contains forward-looking information concerning the effectiveness of S-1226, approval by regulatory agencies of S-1226,
estimated sales volumes and markets, the Company's marketing strategy, the timing and completion of the Company's corporate development
plan (including its exit strategy), funding needs and anticipated sources, the Company's US expansion strategy and matters relating to the
Company's anticipated financing.
The forward-looking information has been made in reliance on certain assumptions that management of the Company believes are
reasonable at this time, including assumptions as to its ability to receive, in a timely manner, necessary regulatory and governmental
approvals; the availability and cost of labour, equipment, supplies and services; and that there will be no significant events occurring outside
of the normal course of business of the Company.
Since forward-looking information addresses future events and conditions, by its very nature it involves inherent risks and uncertainties. Actual
results could differ materially from those currently anticipated due to a number of factors and risks. These include, but are not limited to, the
risks associated with the successful completion of the proposed financing as currently contemplated; timely and cost effective access to
sufficient capital from internal and external sources; changes in capital requirements; changes in legislation; the risks of litigation; changes in
general economic, industry, market and business conditions; and, action by governmental or regulatory authorities including increasing taxes or
other regulations. Consequently, no representation can be, or is being, made with respect to accuracy of the projections or the ability of the
Company to achieve the projected results. The reader is cautioned not to place undue reliance on the forward-looking statements contained
in this presentation. In making an investment decision, prospective investors must make their own determinations as to the reliability of these
forward-looking statements. The Company undertakes no obligation to update publicly or revise any forward-looking information, whether as
a result of new information, future events or otherwise, unless so required by applicable securities laws.
SolAeroMed S-1229 ARDS Drug
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Pre-clinical development
Inhaled cyclodextrin aerosol
Solubilizes & removes cholesterol
Repairs natural lung surfactant
Treatment of Acute Respiratory
Distress Syndrome (ARDS)
SolAeroMed Sleep Apnea Device
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Sleep Apnea Drug/Delivery Device
By-passes CPAP
Inhalation of low level CO2
treats apneas
Pre-clinical development
SolAeroMed S-1226
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New class of Asthma Rescue Drug
New class of Delivery Device
Phase II clinical trials
Asthma: A major lung disease
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¤ 
Global asthma therapeutic market1
n 
n 
¤ 
54 million people asthmatics in our key
markets 2
n 
¤ 
300 million worldwide 1
4 million severe asthmatics in our key
markets
n 
¤ 
2013 - $15.9 billion
growing at 3.8% per year
Prevalence of 5-10% 3,4
3.7 million asthma hospital ER visits each
year in our key markets 5,6,7
n 
~7% of asthmatics
Albuterol: Current Standard of Care
7
When existing treatment doesn’t work in
our key markets.
¤ 
¤ 
3.7M Emergency Department visits / year8
Patients are treated with higher doses of same
drugs they use at home (e.g. Albuterol)
n 
¤ 
No alternative exists or in development pipeline
740,000/year admitted to hospital (10-30%)9
n 
Average 3.6 days of enhanced hospital care
n 
intubation and mechanical ventilation
¤ 
$5.3 billion/year Hospital costs 10
¤ 
> 20,000 asthma deaths/year 1
Treatment Gap: S-1226
8
¤ 
NEW treatment for asthma with a DIFFERENT
mechanism of action than Albuterol and
similar B-agonists.
¤ 
SolAeroMed S-1226
¤ 
New mechanism of action
¤ 
Fast & Sustained bronchodilation
SolAeroMed Asthma R&D
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¤ 
1995 asthma research with Canadian founders
n 
n 
Understand cause & prevention of asthma deaths
R&D around new biophysical drug technology
Mucous plugs Drug aerosol can’t get to where it’s needed S-1226TM – Novel Mechanism of Action
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S1226: Perflubron & CO2-enriched air
n 
Drugs well described & safe – each have regulatory approval
n 
Off the shelf formulation & delivery device
Unique Biophysical mechanism of action neither adrenergic or
cholinergic.
n 
Dialation via epithelial receptors and vagal C-fibres and sustained by
the biophysical action of perflubron and its interaction with natural
lung surfactants
n 
Will work when other drugs do not.
Fast & sustained bronchodilation
S-1226TM – Fast Acting
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Post-­‐MCh Pre-­‐MCh Tissue dye
0 second treatment 1 second treatment 2 seconds treatment 3 seconds treatment View at www.SolAeroMed.com/S-­‐1226 4 seconds treatment Fast & Long Lasting Bronchodilation
12
60
% Opening of Airways 50
40
No treatment
30
Albuterol
20
S-1226™ (12%)
10
0
Immediately
10 minutes
20 minutes
Time A@er Treatment CessaAon S-1226TM – Drug Patent
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¨ 
S-1226 drug patents issued in major markets
¤ 
¤ 
¤ 
¤ 
¨ 
Patent claims:
¤ 
¤ 
¨ 
¨ 
Australia
Canada
Europe
USA
Composition of matter and method to treat
Both mono and combination therapies
Drug Patent protection to 2026 (2028
USA)
IP enhanced with Delivery Device Patent
Early formulation and delivery device
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Circulaire II
CO2 enriched air
Perflubron PFB3
S-­‐1226TM S-1226TM – Portable Delivery Device
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¤ 
¤ 
¤ 
Claim drug GAS and drug VAPOUR in a portable delivery device to treat
respiratory disease
Protects S1226 as well as all other gas/vapour respiratory drug devices !
Patent protection to 2036
S-1226 Development
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2005-­‐2015 Nonclinical Research Drug Screening Compare vs Salbutamol Find OpDmal Dose ✓
✓
✓
Manufacturing Build Prototype Secure Suppliers Minimize COGS File patents ✓
✓
✓
✓
Clinical Development Phase I Phase IIa – Proof of Concept ✓ Q3 2015 2015-­‐2020 Phase IIa – Dose response in late phase (N=36) Phase Iib Phase IIIs S-­‐1226 Portable Device Clinical Development Device Development and Clinical Trials $1M $5.0M $10M $20M Exit Strategy
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¤ 
License or Acquisition
¤ 
At anytime
¤ 
Acquisitions in this space
n 
n 
Median $300M
Range $50-$500M
S-1226TM – Target Markets
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¤ 
S-1226 treatment in Emergency Rooms
“Preceding albuterol for acute asthma exacerbation”
n 
n 
n 
¤ 
S-1226 portable rescue device
n 
n 
n 
¤ 
Estimated peak sales of $119M
Lifetime sales ~$755M - $2.7B
Less than 10% COGS
Novel IP on unique drug & drug delivery device
Estimated peak sales of $200 million
lifetime sales ~$2B
Combination drug therapies
n 
n 
Combine S-1226 to make other inhaled drugs more effective
$2B - $4B Sales 3, 10, 16, 29
S-1226 summary
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n  Novel
therapeutic asthma drug
n  Minimal safety concerns
n  Unique mechanism of action
n  Complements existing therapies
n  Strong IP on both drug (2026) & device (2036)
n  Advanced drug development stage (Phase IIa)
n  Defined Drug & Device Development Path
n  Compelling Markets
n  Exit by Acquisition or License
SolAeroMed Management Team
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President and CEO - John Dennis, PhD
A respiratory drug delivery specialist and consultant to big pharma
Chief Scientific Officer & Co-Founder - Francis Green, MD
A respiratory pathologist with expertise in the human and animal models
of asthma and inhalation toxicology
Chief Financial Officer - Gareth Lewis, MBT, MBA, CMA
A financial management professional with expertise in strategic planning,
financial performance, and risk management.
Clinical Lead: Richard Leigh, MD, PhD
A clinical respirologist-scientist and the GSK-CIHR Professor of Inflammatory
Lung Disease
SolAeroMed Board of Directors
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In addition to John Dennis and Francis Green
Andy Clark, PhD
Formerly Site Head and CTO of Novartis. Previously, at Nektar therapeutics he helped raise more
than $500MM and was a key player in the sale of Nektar’s Pulmonary business for $115MM.
Ian McAffer
Co-founder that bought Steripak Ltd., a sterile product contract manufacturer. Five years later,
sold to Ivax for GB£ 22 million. In 2000, formed Breath Ltd which was sold as part of Arrow Group in
2009 for US$ 2.05 billion.
Gwyn Humphries, PhD
Co-founder and CEO of a spin-out company from Bradford University (Bradford Particle Design
Ltd). The company was acquired by Inhale Therapeutic Systems for $200M.
Michael Flack
Practices in the area of business law and technology enterprises. Acts as SolAeroMed’s principal
council.
Phyllis C. Kane
has a proven track record in policy development, visioning,
fundraising, networking and team leadership. .
SolAeroMed Financial Overview
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¨ 
Cash Investment $1.4M ($200k founders)
¨ 
Total grant funding $2.5M
¨ 
SolAeroMed maintains low burn rate:
¤  Management, Board & Consultants work for equity
¤  Grant subsidized employees, contractors, offices & labs
¨ 
Burn rate will progressively increase
¨ 
$10M Current Valuation
¨ 
2 million outstanding shares
References
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1. 
2. 
3. 
4. 
5. 
6. 
7. 
8. 
9. 
Masoli M et al., (2004). The global burden of asthma: executive summary of the GINA Dissemination Committee report.
Allergy; 59(5): 469-478.
Key markets include: US, Canada, Australia, Austria, Belgium, Denmark, France, Germany, Greece, Italy, Luxembourg,
Netherlands, Spain, Sweden, Switzerland, UK.
Barnes, P. J. (2012). Severe asthma: advances in current management and future therapy. Journal of Allergy and Clinical
Immunology, 129(1), 48-59.
Heaney, L. G., Bel, E. H., Park, H. S., & Wenzel, S. (2013). Section 2.3. Severe Asthma. WAO White Book on Allergy, 39.
American Lung Association. September 2012. Trends in Asthma Morbidity and Mortality. Accessed on September 23, 2013
at http://www.lung.org/finding-cures/our-research/trend-reports/asthma-trend-report.pdf
Cleveland.com. (2012). Asthma hospital stays preventable with home visits, experts say. Accessed on September 23, 2013
at http://www.cleveland.com/healthfit/index.ssf/2012/09/asthma_hospital_stays_preventa.html
The 6.8% of hospital visits is based on 1.8 million hospital visits in the US as a proportion of the total asthma population in
the US.
Based on the calculation of 6.8% of asthmatics visiting an ER each year in the US expanded for SolAeroMed’s key markets.
Louie, S., Morrissey, B. M., Kenyon, N. J., Albertson, T. E., & Avdalovic, M. V. (2012). The Critically Ill Asthmatic: from ICU to
Discharge. In Bronchial Asthma (pp. 203-228). Springer New York.
References
24
10. 
11. 
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Asthma Initiative of Michigan. (no date). Asthma Cost. Accessed on September 23, 2013 at http://www.getasthmahelp.org/
michigan-asthma-statistics-cost.aspx
Rowe, B.H., Bota, G.W., Clark, S. et. al. (2007). Comparison of Canadian versus American emergency department visits for
acute asthma. Canadian Respiratory Journal, 14(6), 331-337.
FiercePharma. November 20, 2012. Top 20 generic molecules worldwide. Accessed on September 23, 2013 at http://
www.fiercepharma.com/special-reports/top-20-generic-molecules-worldwide
National Institutes of Health, National Heart, Lung, and Blood Insititute. (1999). Data Fact Sheet – Asthma Statistics.
Accessed on September 23, 2013 at http://www.nhlbi.nih.gov/health/prof/lung/asthma/asthstat.pdf
El Mays, T., Choudhury, P., Leigh, R., et al. (2011). A Potential Life Saving Treatment of Severe Acute Asthma. Chest,
140(4_Meeting Abstracts), 239A.
Investopedia US. (2012). Using DCF in Biotech Valuation. Accessed on September 23, 2013 at http://
www.investopedia.com/articles/stocks/06/biotechvaluation.asp
Partridge, M.R. (2007). Examining the unmet need in adults with severe asthma. European Respiratory Review, 16(104),
67-72.
SAMi manufacturing cost estimates, supported by verbal quotes from suppliers
Statistics Canada. June 17, 2013. Asthma, by sex, provinces and territories. Accessed on September 23, 2013 at http://
www.statcan.gc.ca/tables-tableaux/sum-som/l01/cst01/health50a-eng.htm
European Federation of Allergy and Airways Diseases Patients Associations. Asthma. Accessed on September 23, 2013 at
http://www.efanet.org/asthma/
References
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21. 
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Australian Centre for Asthma Monitoring 2011. Asthma in Australia 2011: with a focus chapter on chronic obstructive
pulmonary disease. Asthma series no. 4. Cat. No. ACM 22. Canberra: AIHW. Accessed on September 23, 2013 at http://
www.aihw.gov.au/publication-detail/?id=10737420159
Statista. Top Ten Asthma Drugs in the U.S. by Revenue 2011-2012. Accessed on September 23, 2013 at http://
www.statista.com/statistics/242506/revenues-of-top-asthma-drugs-in-the-us-2011-2012/ and SolAeroMed Inc. market
analysis
Actimis Pharmaceuticals, Inc., 2008. Boehringer Ingelheim to Acquire Actimis Pharmaceuticals. Press Release June 17, 2008.
Alexion Pharmaceuticals, Inc. 2011. Alexion Acquires Taligen Therapeutics and Creates Translational Medicine Group to
Accelerate Development of Expanded Portfolio. Press Release January 31, 2011.
24. 
Amira Pharmaceuticals, Inc., 2011. Bristol-Myers Squibb to acquire Amira Pharmaceuticals. Press Release July 21, 2011.
25. 
BioCentury, 2011. BioCentury, Volume 19, Number 23. Article Date May 30, 2011.
21. 
BioSpace, Inc., 2007. AstraZeneca PLC (AZN) to Pay Up to $310 Million for Verus Pharmceuticals' Asthma Programs. Article
Date September 24, 2007.
22. 
Boston Scientific Corporation, 2010. Boston Scientific to Aquire Asthmatx. Press Release September 20, 2010.
23. 
Cephalon Inc., 2010. Cephalon Exercises its Option to Acquire Ception Therapeutics. Press Release February 23, 2010.
24. 
Cornerstone Therapeutics Inc., 2009. Cornerstone Therapeutics Announces $70 Million Strategic Transaction With Chiesi
Farmaceutici SpA. Press Release May 7, 2009.
References
26
25. 
26. 
27. 
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29. 
Hartford Business, 2011. Taligen deal may cost Alexion up to $367M. Article Date February 7, 2011.
Orexo AB, 2007. Orexo to acquire Biolipox - building a specialty pharma company driven by innovation. Press Release
October 15, 2007.
RespiVert Ltd., 2010. Centocor Ortho Biotech Inc. Acquires RespiVert Ltd., Strengthens Pulmonary Focus. Press Release June 1,
2010.
Sandoz, 2010. Sandoz to acquire Oriel Therapeutics, gaining rights to portfolio of respiratory products targeting asthma and
COPD. Press Release April 19, 2010.
The Pharmaceutical Industry in Figures, Key Data 2013, European Federation of Pharmaceutical Industries and Associations.
Current Share Capital (as of Sept 2014)
27
Undiluted Shares
Outstanding shares
Price per share
Total shareholder value
2,029,093
$ 5.00
$ 10,145,465
Diluted Shares
Outstanding shares
Outstanding options
2,029,093
170,798
2,199,897